Kornimate/medical-research-clean huggingface dataset:
hydoxycarbamide and l-carnitine therapy in sickle cell anemia

Conditions: Sickle Cell Disease

Summary: the role of the combination therapy of hydroxyurea and l-carnitine was studied in thalassemic patients. nevertheless its role in sickle cell anemia patients was not investigated

sickle cell disease (scd) is a common monogenic disorder affecting over 100,000 people in the united states alone, and millions more worldwide. this often devastating disease is characterized by red blood cell (rbc) sickling; chronic hemolytic anemia; episodic vaso-occlusion associated with severe pain and inflammation; acute and cumulative organ damage that manifests as stroke, acute chest syndrome, sickle lung disease, pulmonary hypertension nephropathy and end-stage renal disease; and other chronic morbidities. lives of patients with scd are characterized by frequent episodes of severe pain (vaso-occlusive events or "crises"); acute organ dysfunction, including a pneumonia-like syndrome termed acute chest syndrome, and strokes starting in childhood; and progressive multi-organ damage. not surprisingly, patients with scd have very high health care utilization (over $1 billion/year in healthcare costs in the united states alone, and a median life-expectancy of only \~45-58 years, compared to the life expectancy of 78.2 years overall in the united states. although it is licensed in the united states for administration to sickle cell patients who have ≥ 3 crises a year in steady state, hydroxyurea (hu) remains unlicensed in most countries where it is regarded as an experimental drug in those areas, where hu is unlicensed for scd, it is offered to patients who have ≥ 5 crises a year; or 3-4 crises a year with either neutrophil count ≥ 10 × 109/l or platelet count ≥ 500 × 109/l in steady state ; bearing in mind that the reference range for neutrophil count in black people is 1-3 × 109/l, and is 100-300 × 109/l for platelets . since high neutrophil count in steady state is a marker of severe scd , these criteria usually identify individuals who have a clinical course sufficiently severe to ensure that the benefits of hydroxyurea therapy justify the potential risks. hu therapy is offered if the patient does not want to have (more) children, and is weighed against any severe impairment of liver or kidney function, or blood cytopenia. hu is unlicensed in most countries because the long-term adverse effects are unknown, not because the clinical efficacy is in doubt. in fact, after over 9 years of follow-up, hbss subjects who received hu in the us placebo-controlled trial, had significantly less painful crises, acute chest syndrome, and mortality . potential long-term toxic effects that reduce enthusiasm for hu include teratogenicity, carcinogenesis and, for young children, impaired cognitive development.

Eligibility criteria:
inclusion criteria: * patients with sickle cell disease * not welling for pregnancy in females or to father a baby in males * frequent episodes * non-compliance to transfusion exclusion criteria: * \<18 years * hypersensitivity to hydroxycarbamide or l-carnitine * pregnancy * other chronic infection or inflammation
adjuvant radiotherapy in breast with intensity modulated by tomotherapy:

Conditions: Breast Cancer

Summary: adjuvant radiotherapy after lumpectomy allows a local long-term control of the order 85 to 95% with a survival rate equivalent to that of the totally mastectomy. the diminution of the local recurrence rate after irradiation post- lumpectomy is also associated to a best global survival than only the surgery. the adjuvant radiotherapy after partially or totally mastectomy for the progressive tumors is a therapeutic standard (early breast cancer trialists' collaborative group 2011). the aim of our trial of routine care is to record our practices under this breast adjuvant radiotherapy.

patients responding criteria for selection and not objecting to participate in this trial will address the quality of life questionnaires at baseline and during their standard follow-up (1, 6, 12 and 24 months after the end of radiotherapy). the data of toxicity and disease-free survival will be collected from data on medical record of the patient. the therapeutic support and monitoring are standard.

Eligibility criteria:
inclusion criteria: 1-patient with breast cancer proved by histology and treated surgically 2. relevant of adjuvant radiotherapy after partial or total mastectomy with or without lymph node irradiation 3- age ≥ 18 years 4- information and no opposition to the patient exclusion criteria: 1. - metastatic disease 2. - patient having another severe disease or uncontrolled which could jeopardize the trial participation 3. - pregnant or breastfeeding woman 4-inability to do follow-up medical care of clinical trial for geographical, social or psychological reasons

Keywords: breast cancer radiotherapy intensity modulation toxicity
new biomarkers evaluating ovarian cancer

Conditions: Adnexal Mass

Summary: the purpose of this study is to evaluate new biomarkers for patients presenting to a physician for surgery to remove a mass in their pelvis and to continue to evaluate these types of patients using the roma algorithm for post-market benefits.


Eligibility criteria:
inclusion criteria: * female, age 18 years or older * adnexal mass present documented by imaging * scheduled to undergo surgery based on a finding of adnexal mass * able and willing to provide informed consent exclusion criteria: * previous history of ovarian cancer * previous history of bilateral oophorectomy * currently known to be pregnant * unable to provide informed consent

Keywords: ovarian cancer adnexal mass pelvic mass
pedaling exercises for disability and activity limitations

Conditions: Stroke

Summary: this purpose of this study is to determine the effect of different levels of feedback on participation in a home exercise regimen and the amount of walking performed by patients recently discharged from the acute rehabilitation setting.

the ucfit (university of california's u cycle to fitness) device is a standard commercial arm and leg restorator modified to collect pedaling data and to transmit it wirelessly to a central database, allowing for remote exercise monitoring. in this study, patients with stroke will perform pedaling exercise on the ucfit device prior to and then for a period of twelve weeks after discharge to home from inpatient rehabilitation. differing levels of feedback will be provided to study subjects and corresponding changes in the amount of pedaling and walking performed will be identified. the results of this study will offer insight into the activity levels of disabled persons in their home environments. furthermore, it will help in the identification of strategies that can increase activity levels in the critical period after discharge to home.

Eligibility criteria:
inclusion criteria: * diagnosis of stroke * no major contraindications to participating in light-to-moderate exertion * able to follow and retain verbal directions to carry out simple lower extremity repetitive exercises * planned discharge to home with family available to assist exclusion criteria: * pre-morbid limitations in walking related to another medical disease * body mass index \>30 * fractures or contractures that prevent use of an extremity for pedaling * impairment in cognition that precludes a full understanding of the risks and benefits of this study

Keywords: disability walking feedback exercise
surgical positioning of the arm during thoracic surgery -effect on shoulder pain after surgery?

Conditions: Lung Cancer

Summary: up to 85% experience shoulder pain after thoracic surgery, especially on the same side as surgery are performed. referred phrenic nerve pain is probably one cause of ipsilateral shoulder pain (isp), and positioning of the arm during surgery another. studies indicates that isp can be caused by the positioning of the patient during surgery due to muscle -and ligament strain. can a change in the surgical positioning (less press and stretch) of the ipsilateral arm effect the shoulder pain after thoracic surgery?


Eligibility criteria:
inclusion criteria: * men and women;18 years and older * thoracotomy for lung cancer * video assisted thoracic surgery for lung cancer. exclusion criteria: * received treatment for shoulder pain * use pain medication on regular basis * under 18 year * length of stay in icu more than 24 hours after surgery * does not understand the native language

Keywords: ipsilateral shoulder pain surgical positioning lung cancer thoracotomy video assisted thoracic surgery
effectiveness of recovery protocols in elite professional young soccer players

Conditions: Soccer; Physical Stress; Fatigue

Summary: the main objective of this project is to compare two recovery protocols, including nutritional and neuromuscular strategies on inmune, physiological and muscular responses.

a randomized controlled trial will be performed and players will be assigned in one of the two groups after their participation in a football game. the investigators will take baseline measures before the game and post-competition measures immediately after (after recovery intervention) and at 24, 36, 48 hours after the recovery intervention.

Eligibility criteria:
inclusion criteria: * elite young professional football players * 75 minutes (at least) of game participation exclusion criteria: * goalkeepers * injured players * players unable to perform at their best * players under medication

Keywords: performance recovery fatigue soccer
bioptron light therapy for dysmenorrhea in obese adolesences: rct

Conditions: Dysmenorrhea Primary; Obesity and Overweight

Summary: dysmenorrhea is the most common health problem in women in the reproductive age(bakhsh et al., 2022). the primary dysmenorrhea starts shortly after the menarche the pain lasting 1 to 3 days that start just before or at the onset of menstruation with the absence of other gynecological symptoms (itani et al., 2022). primary dysmenorrhea can reduce the quality of life and social activities of women(esan et al., 2024). there is a relationship between body mass composition and primary dysmenorrhea and as the value of body mass index and body fat percentages goes on increasing in females, the severity of primary dysmenorrhea also increased (wu et al., 2022). bioptron® light therapy system is a device that contains an optical unit. this unit emits light with an electromagnetic spectrum produced by the sun, but without the ultraviolet rays and it is significant with four main characteristics which are polarization, polychromatic, incoherence and low energy light (raeissadat et al., 2014). the purpose of the study the aim of the study is to investigate the effect of bioptron© light therapy on primary dysmenorrhoea outcomes as pain and quality of life among obese adolescence.


Eligibility criteria:
inclusion criteria: * 144 female adolescences suffering from primary dysmenorrhea pain determined according to the sample size calculation adapted from (gu et al., 2022). * they will be selected from the outpatient's clinic of the faculty of physical therapy sinai university. * their chronological age ranged from 16 to 18 years old. exclusion criteria: * those who were taking anti-psychotic or anti-depressant medications, patients with any skin lesion or infection. * gynecological disorders included cervical cancer, ovarian tumors, endometriosis, uterine fibroids, polycystic ovarian syndrome, and other conditions that can affect menstruation.
a study of baricitinib (ly3009104) in participants with severe or very severe alopecia areata

Conditions: Alopecia Areata

Summary: this study is designed to select up to two doses of baricitinib (referred to as low dose and high dose) and assess their efficacy and safety for the treatment of severe or very severe alopecia areata. an additional subpopulation of 60 participants in the us will enroll in the open-label addenda.


Eligibility criteria:
inclusion criteria: * are at least 18 years and ≤60 years for males (≤70 years of age for females) at the time of informed consent. * must self-identify as either black or african american in race in the open label addenda. * have severe or very severe aa, as determined by all of the following: * current aa episode of more than 6 months' duration and hair loss encompassing ≥50% of the scalp, as measured by salt alopecia areata investigator global assessment (aa-iga) of 3 or 4) at screening and baseline. * no spontaneous improvement over the past 6 months. * current episode of severe or very severe aa of less than 8 years. * male or nonpregnant, nonbreastfeeding female participants. exclusion criteria: * primarily "diffuse" type of aa. * are currently experiencing other forms of alopecia or any other concomitant conditions that would interfere with evaluations of the effect of study medication on aa. * previously treated with an oral janus kinase (jak) inhibitor and had an inadequate response (for example, absence of significant terminal hair growth after at least 12 weeks of treatment).
c-pulse® system european multicenter study

Conditions: Heart Failure

Summary: the study is designed to observe the clinical outcomes of heart failure patients treated with c-pulse® system in the usual manner and according to the approved indications and contraindications.

evaluation of the post-market clinical performance and safety of the c-pulse® system for the treatment of heart failure in the population of patients who meet the approved clinical conditions provided in the indications and contraindications.

Eligibility criteria:
inclusion criteria: * patient is 18 years or older * patients with moderate to severe ambulatory heart failure \[american college of cardiology/american heart association (acc/aha) stage c; nyha class iii/iv ambulatory\], who are refractory to optimal medical therapy * patients who are non-responders to crt pacemaker therapy * patient has signed and dated the investigation informed consent form exclusion criteria: * evidence of significant ascending aortic calcification on postero-anterior chest x-ray or ct scan * moderate or severe atherosclerotic aortic disease * ascending aorto-coronary artery bypass grafts * any history of aortic dissection * connective tissue disorder such as marfans disease * aorta not conforming to specified dimensional constraints * patient has severe mitral valve incompetence, grade 4+ * patient has moderate to severe aortic valve incompetence, grade 2 - 4+ * patient has systolic blood pressure less than 90 or greater than 140mmhg * presence of active systemic infection * presence of bleeding or coagulation disorder (relative)

Keywords: heart failure nyha class iii nyha class iv
diagnosis accuracy of hemoconcentration to detect hypovolemia during crrt

Conditions: Continuous Renal Replacement Therapy; Intensive Care Unit; Hypovolemia; Fluid Overload

Summary: the aim of the study is to analyze if blood protein concentration variation during continuous renal replacement therapy (crrt) with fluid removal can predict a decrease of 15 % of cardiac index in intensive care unit (icu) patients. blood protein concentration, clinical data describing hemodynamic status (providing data from pulsion medical system picco2 ® monitoring), including preload dependency evaluation with passive leg raising, are collected at different times: before initiation of fluid removal, and after the first episode of hypotension or one hour after initiation of fluid removal.

the aim of the study is to analyze if blood protein concentration variation during continuous renal replacement therapy (crrt) with fluid removal can predict a decrease of 15 % of cardiac index in intensive care unit (icu) patients. blood protein concentration, clinical data describing hemodynamic status (providing data from pulsion medical system picco2 ® monitoring), including preload dependency evaluation with passive leg raising, are collected at different times: before initiation of fluid removal, and after the first episode of hypotension or one hour after initiation of fluid removal.

Eligibility criteria:
inclusion criteria: * up to 18 years old * continuous renal replacement therapy * suspicion of fluid overload * prescription of fluid removal by the intensivist * picco2 monitoring exclusion criteria: * pregnancy * intra abdominal hypertension * moribund patient * abdominal hypertension
surveillance and alert-based multiparameter monitoring to reduce worsening heart failure events

Conditions: Heart Failure

Summary: the main goal of this study is to use data from the bodyport cardiac scale to help detect of worsening heart failure (hf) early.

the overarching goal of this prospective, multicenter study is to utilize data from the bodyport cardiac scale to develop an index that allows for the early detection of worsening heart failure (hf). the bodyport cardiac scale is capable of measuring key hf parameters of congestion and cardiac perfusion on a regular basis in a patient's home. these data will be combined into a composite index that may be used to identify patients at increased risk for decompensation, inform the reason for their decline, and offer the possibility to remotely optimize therapy to prevent further worsening hf. the scale-hf program will consist of multiple phases. for scale-hf 1, patients will be prospectively enrolled and utilize the bodyport cardiac scale on a daily basis. patients and clinicians will be blinded to the results other than data readily available from other devices such as body weight. there will be no attempt to influence clinical practice. patients will be followed remotely for suspected clinical events.

Eligibility criteria:
inclusion criteria: 1. provide informed consent before trial enrollment 2. age ≥ 18 years 3. a diagnosis of symptomatic hf including a worsening hf event in the preceding 12 months. worsening hf events will be determined by local clinician-investigators and will typically include the following: a) hf symptoms (eg, dyspnea, fatigue); b) hf signs (eg, elevated jugular venous pressure, peripheral edema), or laboratory/imaging evidence of hf (eg, pulmonary congestion on chest x-ray, elevated natriuretic peptide levels) during the event, and treatments targeting acute hf (eg, intravenous diuretics, vasodilators, or inotropes). exclusion criteria: 1. weight \>170 kg 2. use of chronic inotropic therapy 3. prior heart transplant or currently listed for heart transplant 4. current or planned left ventricular assistance device 5. chronic kidney disease requiring chronic dialysis 6. unknown left ventricular ejection fraction (lvef). the lvef should be based on the most recent local measurement using echocardiography, multigated acquisition scan, computed tomography scanning, magnetic resonance imaging, or ventricular angiography. patients with preserved and reduced lvef will be permitted in the study though enrollment may be capped to ensure no more than approximately 2/3 of the total enrollment includes patients with preserved or reduced lvef. 7. terminal illness other than hf, such as malignancy, or with a life expectancy of less than 1 year as determined by the enrolling clinician-investigator 8. unable to participate in longitudinal follow-up including daily use of the bodyport scale. patients must be able to stand independently on the bodyport scale.

Keywords: bodyport heart failure decompensation
paclitaxel and capecitabine in treating women with metastatic breast cancer

Conditions: Breast Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: phase ii trial to study the effectiveness of paclitaxel and capecitabine in treating women who have metastatic breast cancer.

objectives: i. determine the safety, response rate, and efficacy of combination therapy with paclitaxel and capecitabine as first or second line therapy in women with metastatic breast cancer. outline: this is a multicenter study. patients receive paclitaxel iv over 3 hours on day 1 and capecitabine orally twice daily on days 1-14. treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. patients are followed for survival status every 3 months upon completion of treatment. projected accrual: a total of 60 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically or cytologically confirmed metastatic breast cancer bidimensionally measurable disease hormone receptor status: not specified patient characteristics: age: 18 to 75 sex: female menopausal status: not specified performance status: karnofsky 70-100% life expectancy: not specified hematopoietic: anc at least 1,500/mm3 platelet count at least 100,000/mm3 hepatic: bilirubin less than 1.5 times upper limit of normal (uln) renal: creatinine less than 1.5 times uln other: not pregnant or nursing negative pregnancy test fertile patients must use effective contraception prior concurrent therapy: biologic therapy: not specified chemotherapy: eligible patients may have received prior chemotherapy in metastatic or adjuvant setting with the following exceptions: at least 12 months since prior fluoropyrimidine therapy at least 12 months since prior taxane therapy only 1 previous chemotherapeutic regimen in the metastatic setting endocrine therapy: not specified radiotherapy: at least 4 weeks since prior radiotherapy surgery: not specified

Keywords: stage iv breast cancer recurrent breast cancer
bare metal stent versus drug coated balloon with provisional stenting in non-st-elevation myocardial infarction

Conditions: Coronary Heart Disease; NSTEMI

Summary: the aim of the present trial is to assess the efficacy of the standalone use of sequent(r) please coated balloon compared to a bare metal stent (bms) in patients with nstemi.

the aim of the present trial is to assess the efficacy of the standalone use of sequent(r) please coated balloon compared to a bare metal stent (bms) in patients with nstemi. primary efficacy endpoint will be mace (cardiac mortality, reinfarction, and target lesion revascularization) after 9 months.

Eligibility criteria:
inclusion criteria: * nstemi with * ischemic symptoms (angina pectoris) \> 30 minutes * last symptoms within 72 hours before randomization * positive cardiac troponin t, i, or hs-troponin above 99th percentile * age \> 18 years * identifiable culprit lesion without angiographic evidence of large thrombus with intended early pci (treatment of up to two lesions allowed) exclusion criteria: * cardiogenic shock * st-elevation myocardial infarction * no identifiable culprit lesion, indication for acute bypass surgery * comorbidity with limited life expectancy \< 9-12 months * contraindication for treatment with heparin, asa and thienopyridines

Keywords: drug coated balloon nstemi